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Completed

NCT Number: NCT02241759

Study of the Electrocardiographic Effects of TA-8995

A study in healthy males and females to see if a high single dose of TA-8995 has an effect on the ECG QTcF interval.

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Key information

Conditions

Dyslipidaemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit Ltd

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or females of non-child bearing potential

Exclusion criteria

  • Receiving any other drug therapy
  • Clinically significant medical history
  • Abnormal ECGs or vital signs

Treatment and study plan

TA-8995

Drug

moxifloxacin

Drug

Placebo

Drug

Primary outcomes

  1. Change from baseline in QT interval corrected for heart rate (QTc) for TA-8995 versus placebo

    Time frame: 4 days

Secondary outcomes

  1. Relationship between plasma levels of TA-8995 and the QTcF effect

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

Xention Ltd

Industry

Registry information

Official study title

A Phase I, Single-Centre, Randomised, Placebo and Positive- Controlled, Parallel-Group Study of the Electrocardiographic Effects of TA-8995 in Healthy Male and Female Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 16, 2014
Registry last updated
Feb 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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